What is FDA product code DWJ?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Cardiovascular › TherapeuticSystem, Thermal Regulating

Hot Dog Pediatric Head Warming Wrap, Large

Name: Hot Dog Pediatric Head Warming Wrap, Large
Brand: Hot Dog Pediatric Head Warming Wrap, Large

Labeled: Hot Dog Pediatric Head Warming Wrap, Large B271

Registry build 21.09.26

8manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

13recalls on this code

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DWJ
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Copious Intl., Inc.	Heyuan, Guangdong Province		Contract manufacturer	11
Jiangyin Puremed	Jiangyin	Jiangsu	Contract manufacturer	7
Betacera Inc.	Suzhou	Jiangsu	Contract manufacturer	3
Shanghai Xodus Medical Company Limited	Shanghai	Shanghai	Specification developer	25
Hangzhou Tappa Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	3
Jiangmen Dacheng Medical Equipment Co., Ltd.	Jiangmen	Guangdong	Contract manufacturer	1

Record

Regulatory record for Hot Dog Pediatric Head Warming Wrap, Large
Listed by	Augustine Temperature Management, LLC, United States
FDA product code	DWJ
Device type	System, Thermal Regulating
Device class	Class 2
Regulation	21 CFR 870.5900
Establishment	Specification developer, Manufacturer
510(k)	K112488
Record published	2016-09-28
Record revised	2025-11-20 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	expiry date, serial number

Catalogue Numbers

Catalogue numbers for Hot Dog Pediatric Head Warming Wrap, Large
Catalogue number	Size	Status
B271		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mistral-Air	The Surgical Company International B.V.	114
Bair Hugger™	3M Company	99
IOB	Jiangmen Dacheng Medical Equipment Co., Ltd.	68
IOB	Iob Medical, Inc.	61
3M™ Bair Hugger™	3M Company	61
Cocoon	Care Essentials PTY Ltd	59
Soft Air	Adroit Medical Systems, Inc.	56
Level 1	ICU Medical, Inc	49
System, Thermal Regulating	Hangzhou Tappa Medical Technology Co., Ltd.	47
PremierPro	Prestige Ameritech	39
Bair Paws™	3M Company	30
SourceMark	Sourcemark, LLC.	25

Showing 12 of 166. All products under System, Thermal Regulating

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232627	2024-04-18
K230866	2023-06-29
K220941	2022-09-23
K201779	2020-09-11

Recalls

13 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2024-12-16	Class II	Device Design	There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused	3 units
2024-12-16	Class II	Device Design	There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused	1 unit
2024-12-16	Class II	Device Design	There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused	4 units
2024-12-04	Class II	Device Design	Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code “EA POST”.	116 units
2024-12-04	Class II	Device Design	Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code “EA POST”.	135 units
2024-12-04	Class II	Device Design	Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code “EA POST”.	1776 units
2024-02-15	Class II	Device Design	Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact.	7 unit
2024-02-15	Class II	Device Design	Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact.	20 units
2022-03-14	Class II	Device Design	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code “EA POST”.	1113 units
2022-03-14	Class II	Device Design	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code “EA POST”.	817 units
2022-03-14	Class II	Device Design	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code “EA POST”.	17 units
2022-03-14	Class II	Device Design	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code “EA POST”.	2271 units
2022-03-14	Class II	Device Design	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code “EA POST”.	77 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.